Category Archives: 2016

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Source: Abstract #PS-101 Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection—K.F. Murray, et al.

Study Aims and Results: The U.S. Food and Drug Administration (FDA recently expanded the use of Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to adolescents 12 years and older who have hepatitis C virus (HCV). However, the only FDA-approved hep C treatment for children under age 12 is peginterferon plus ribavirin, a combination that has many side effects and poor response rates when compared to the new DAAs. This ledipasvir/sofosbuvir +/- ribavirin study enrolled 90 HCV+ children, ages 6–11 years old. The SVR4 rate among the 88 patients who completed the posttreatment Week 4 visit was 99%; one GT1a patient relapsed after 12 weeks.

Conclusion: This all-oral, interferon-free regimen was well tolerated, suggesting its potential as an important treatment option for children 6–11 years old. The study is continuing in children aged 3–5 years old.

Editorial Comments: This study is small and missing the final week 12 data. However, with few options for children, these results seem robust and point towards a hopeful future for children with hepatitis C. It also increases hope for parents; what parent would want to put their child through 24 to 48 weeks of peginterferon rather than 12 weeks of a DAA?

Note: Statins are a class of drugs used to lower cholesterol levels to prevent heart attack, stroke, and death from heart disease. In the United States, approximately 73 million adults take statins. Statins are considered universally safe. There are, however, side effects such as muscle pain and weakness. Statins and have been linked to increases in diabetes although the numbers in one study was 50 to 100 cases per 10,000 patients.

Study Aims and Results

Studies have already found that statins decreased the risk of the progression to decompensated cirrhosis and death in Veterans with cirrhosis due to hepatitis C. The aim of the current study was to understand if statin use in people with cirrhosis due to hepatitis B, hepatitis C or alcohol related cirrhosis decreases the progression to decompensated cirrhosis, liver cancer, and death.

Patients with cirrhosis in the Taiwan National Health system were identified from 2000 through 2013. A total of 1,350 patients with cirrhosis were enrolled. Statin users and non-users were matched for patient characteristics.

Conclusion

Statin use was found to lower the risk of decompensation (P<.0001),liver cancer (p 0.0009) and death (p<.0001) due to chronic hepatitis B or chronic hepatitis C in a dose-dependent manner. The benefit of statin use for progression to decompensation, however, was found to be “borderline significance” for those who had alcohol-related cirrhosis.

Note: P-value (p-value) is defined as the probability of obtaining by chance a result (in this case) from a clinical trial. A p-value of p <0.05 is deemed as statistically significant. Another way to think about it is that p < 0.0001 means that there less than a one in a thousand chance the clinical trial results are wrong.

Editorial Comments

In regards the lower risk of decompensation, death and liver cancer, the benefits of statin use was significant for those with hepatitis B and C but only borderline for those with alcoholic cirrhosis.

As with any healthcare—educate yourself and work with your healthcare provider to make the best possible choice for your health.

Abstract # FRI-186 Study Aims & Results: Approximately 1/3 of people infected with hepatitis C in the United States pass through the jail and prison system each year.

Study Aims and Results: This abstract is about treating prisoners with the aid of telemedicine. Although prisons would be a perfect place to test and treat people with hepatitis C there are many barriers to treating people in prisons such as the cost of HCV medications and lack of medical providers available to provide care and treatment for the thousands of hepatitis C positive persons in prisons.

Project Echo (Extension for Community Health Outcomes) model has been providing telemedicine to people with hepatitis C and other conditions for more than a decade. It is the basis for this study that took place in New Mexico. New Mexico has a prevalence of 43% of hepatitis C on intake into the state prison system. Project ECHO uses multipoint videoconferencing to guide New Mexico Correction medical providers to treat inmates with hepatitis C.

Fifty-six TeleECHO clinics were held with 115 patients (96% male; 57% genotype 1; 39% genotype 3; 4 % genotype other). By October 31, 2016 –77 patients started treatment and 56 patients completed treatment with post-treatment follow-up. The average age was 49yo; 82% had cirrhosis. The reason for treatment in the non-cirrhotic patients was coinfection with HIV/HCV coinfection.

Conclusion: The cure rates for genotype 1 was 91%; 89% for genotype 3. In the 5 patients who were not cured three relapsed while on treatment, one patient died, and one patient was re-infected, 1 patient relapsed 12 weeks post-treatment with a different genotype.

Editorial Comments: I would like to see this study replicated in other prisons. It seems to be a good model that can be effectively replicated.

Eliminating hepatitis C means that we have to treat and cure everyone with hepatitis C including prisoners. Prison is an optimal place to treat inmates and telemedicine can help achieve this goal. Releasing prisoners cured of hepatitis C into the general population means that we can stop the spread of hepatitis C. It is a public health issue and a humane one.

AASLD 2016 Conference Coverage – Merck

C-Crest: The trial was a phase 2 study of a 3-drug co-formulation of MK-3682 (polymerase inhibitor), grazoprevir (protease inhibitor) plus ruzasvir (NS5A inhibitor) with and without ribavirin to treat HCV genotypes 1, 2 and 3. The treatment period was 8, 12 or 16 weeks. In the people who were previously treated with pegylated interferon plus ribavirin the SVR12/cure rates were 95% to 100% in genotype 1a, 1b and 3. In people with genotype 2 the cure rate was 87% in the 8-week group and a 100% rate in the 12 week group and 96% to 98% in the 16 week groups. There was very little difference in cure rates between the groups who had cirrhosis, and who did/did not receive ribavirin.

C-Surge: An on-going phase 2 study to treat people with genotype 1 who had failed a previous course of a direct-acting antiviral therapy (Harvoni or Zepatier) using MK-3682, grazoprevir and ruzasvir with and without ribavirin. In the group that received ribavirin the treatment duration was 16 weeks; in the group that did not receive ribavirin the treatment duration was 24 weeks. The SVR 8 results were 98% in the 16 week group that received ribavirin and 100% in the 24 week group that did not receive ribavirin.

Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website

AASLD 2016 Conference: AbbVie

Phase 3 Clinical Trials:

Four studies of AbbVie’s two drug combination—glecaprevir (protease inhibitor) and pibrentasvir (NS5A inhibitor) were presented.

Endurance 1:703 genotype 1 non-cirrhotic treatment naïve and treatment experience patients. The patients were treated for 8 or 12 weeks. No ribavirin was used in the study. The cure rates were 99% to 100% across all treatment groups. Endurance 2: 199 genotype 2 non-cirrhotic treatment-naïve and treatment-experience patients treated for 12 weeks achieved 99% to 100%.

Surveyor-II Part 3 Phase 2/3: In genotype 3 patients who were cirrhotic and treatment experienced but who had not been previously treated with a NS5A inhibitor were treated with glecaprevir plus pibrentasvir. Those treated for 12 weeks achieved 91% to 98% cure rates and those treated for 16 weeks achieved 96% cure rates. This treatment was particularly effective for people with end-stage kidney disease.

Surveyor-II Part 4: In genotype 2, 4, 5 or 6 patients without cirrhosis. There were a total of 203 patients—both treatment naïve and treatment experienced (no NS5A treatment experienced). The treatment period was 8 weeks. The cure rates were 98% for genotype 2; 93% for genotype 4; 100% for genotype 5 and 90% for genotype 6—although the number of patients in the genotype 5 and 6 groups were very small.

Expedition-IV: The goal of the study was to treat patients with renal impairment. There were 104 genotype 1 through 6 patients enrolled. The majority of the patients had severe renal impairment, and 82% were on dialysis (filtering of the blood because the kidneys are impaired). The patients were treatment naïve and treatment experienced (no NS5A experienced). The cure rate was 99% (103 of 104)—one patient discontinued treatment before the trial ended.

AbbVie has submitted their study results to the Food and Drug Administration forapproval inDecember.

Alan Franciscus is the Executive Director of the Hepatitis C Support Project and Editor-in-Chief of the HCV Advocate.

AASLD 2016: Treatment of People Who Inject Drugs

People who Inject Drugs (PWIDs) and who are infected with hepatitis C are not generally considered for hepatitis C treatment except in clinical trials. This is troubling because PWIDs are now the largest group of people who are at risk of acquiring hepatitis C. Additionally, a strategy to eliminate hepatitis C has to include a strategy to treat the most at-risk population. This year’s Conference included a presentation “Treatment of HCV in People Who Inject Drugs” by Jason Grebely. I am only going to cover the cure rates and re-infection rates from Dr. Grebely’s presentation.

Treatment: In various phase 3 clinical trials of people on HCV direct-acting antiviral medications the cure rates were 92% to 96% in people on opioid substitution therapy vs. 95% to 98% in people who were not on opioid substitution therapy (OST). In one of the largest clinical trials of people who inject drugs—C-EDGE Co-STAR (elbasvir/grazoprevir), genotypes 1, 4 and 6, treatment naïve patients, fibrosis stage F0 through F4, 12 week treatment duration the cure rate was genotype 1a: 96% (146 of 152 pts) ; genotype 1b: 97% (28 of 29 pts); genotype 4: 100% (11 of 11 pts); genotype 6: 60% (3 of 5 pts). The adherence in the group was 96%.

In other clinical trials of ‘real world’ study of people who inject drugs (heroin 66%; cocaine 62%; other stimulants 46%; OST 40%) and treated with different direct-acting antiviral medications the overall cure rate was 95%.

An overview of reinfection rates after being cured of hepatitis C among PWID were 2% to 3% in people who had a history of reinfection, 6% per year in people who injected drugs after achieving a cure and in one study presented at AASLD 4% per year in people on OST. There was no information given about prevention education—the most important component when treating people who are actively using drugs.

Alan Franciscus is the Executive Director of the Hepatitis Support Project and Editor-in-Chief of the HCV Advocate Website.

– Japan has one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those GT1[1,2,3]– Results demonstrated in CERTAIN-1 study are consistent with recently announced 8-week, GT1 data from the global registrational studies for G/P

NORTH CHICAGO, Ill.,Jan. 9, 2017/PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12rates with 8 weeks of treatment with its investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. In top-line results from the Phase 3 CERTAIN-1 study, 99 percent (n=105/106) of patients without cirrhosis, which represents the majority of HCV patients, and without the Y93H variant achieved sustained virologic response at 12 weeks post treatment (SVR12). The only patient in whom SVR12was not documented in this intent to treat (ITT) population was lost to follow-up.All 23 patients with the Y93H variant were assigned to the G/P arm and achieved SVR12.

These data are the first to be released from registrational studies inJapanas part of AbbVie’s global G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes and with the goal of addressing treatment areas of continued unmet need.

“These initial data in GT1-infected patients, which is the most common type of hepatitis C inJapan, may help to further advance our understanding on how we care for patients in this country,” saidStefan Zeuzem, M.D., Chief of the Department of Medicine at theGoethe UniversityHospital inFrankfurt, Germany. “In the CERTAIN-1 study with the G/P regimen, we see for the first time that 8 weeks of treatment achieved high cure rates in these GT1-infected Japanese patients without cirrhosis.”

Japanhas one of the highest rates of hepatitis C infection in the industrialized world.2Approximately 1 million people are living with hepatitis C inJapan, with 60 to 70 percent of those infected with GT1 chronic HCV.1,3Patients included in the CERTAIN-1 study were further representative of the HCV-infected patient population inJapan, where the prevalence of HCV infection increases with age, by including a majority of patients over 65 years of age.4

“Due to patient characteristics and virological considerations, people living with HCV inJapanhave specific treatment challenges and needs,” saidMichael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “AbbVie’s dedicated G/P registrational clinical development program inJapanreflects our continued commitment to make a real difference in the lives of Japanese patients.”

The CERTAIN-1 study compared the safety and efficacy of 8 weeks of treatment with the investigational G/P regimen, to 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), in GT1 chronic HCV-infected patients. The primary endpoint of the study was met, as 8 weeks of G/P was shown to be non-inferior to 12 weeks of OBV/PTV/r (100 percent SVR12; n=52).

Additionally, in substudy 1 evaluating GT1 patients (treated with G/P) without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), no patients discontinued treatment due to adverse events (AEs). In patients treated with OBV/PTV/r, there was one who discontinued treatment due to AEs. In patients receiving the G/P regimen, the most common AEs, occurring at a rate greater than 5 percent, were nasopharyngitis (inflammation of the throat and nasal passages) and pruritus (itchiness).

About the CERTAIN-1 StudyThe CERTAIN-1 study is a Phase 3, multicenter study evaluating the efficacy, safety and pharmacokinetics (PK) of G/P in Japanese adults. Substudy 1 is randomized, open-label, active-controlled, in genotype 1 (GT1) chronic HCV-infected patients without cirrhosis and who are new to DAA treatment. Patients who tested negative for Y93H resistance associated variant received either 8 weeks of G/P or 12 weeks of OBV/PTV/r (2:1 randomization ratio). All Y93H positive patients were assigned to receive 8 weeks of G/P and all (n=23/23) achieved SVR12. The primary objectives were safety and non-inferiority of G/P compared to OBV/PTV/r.

Substudy 2 is a non-randomized, open-label study evaluating GT1-6 HCV patients with specific treatment challenges, including those with compensated cirrhosis (Child-Pugh A), chronic kidney disease (CKD) and those who were not cured with previous DAA treatment.

Additional data will be presented at an upcoming scientific congress.

About AbbVie’s G/P Clinical Development ProgramAbbVie’s glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need. InJapan, AbbVie studied the G/P regimen in additional dedicated clinical trials due to patient and viral characteristics specific to the Japanese HCV patient population.

G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

G/P is an investigational product and its safety and efficacy have not been established inJapan.

*Patients with a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About VIEKIRAX inJapanVIEKIRAX (ombitasvir/paritaprevir/ritonavir) is indicated for the improvement of viremia in chronic hepatitis C or compensated hepatic cirrhosis C in patients of serogroup 1 (genotype 1) and for chronic hepatitis C in patients of serogroup 2 (genotype 2).

Positive result for HCV RNA should be confirmed before administering VIEKIRAX and decompensated cirrhosis should be excluded.

For genotype 2, since efficacy varies due to subtype and prior treatment experience with or without IFN the benefit-risk of VIEKIRAX treatment should be considered. Since VIEKIRAX is coadministered with ribavirin in genotype 2, precautions for use of the package insert of ribavirin must be confirmed.

When VIEKIRAX is used for patients co-infected with HIV/HCV, administer VIEKIRAX only to patients whose virological suppression has been achieved by anti-HIV therapy as ritonavir may cause resistance against a HIV protease inhibitor.

During the administration of VIEKIRAX, perform liver function tests regularly because hepatic function disorder may occur.

While HCV viral load is decreased, HBV reactivation in patients who are chronic infection of HBV or patients who have a history of HBV infection has been reported after initiation of HCV DAA treatment.

Renal function tests should be performed prior to an initiation and periodically after initiation of VIEKIRAX.

Co-administration of VIEKIRAX with drugs that are substrates of CYP3A4, P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, potentially requiring dose adjustment or clinical monitoring.

The safety of VIEKIRAX in pregnant women has not been established. VIEKIRAX should be used in pregnant women and women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. VIEKIRAX in combination with ribavirin must not be used in patients who are pregnant or may be pregnant.

Do not administer VIEKIRAX to nursing mothers. If VIEKIRAX is administered to a nursing mother by necessity, breast feeding must be discontinued during treatment.

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visitwww.abbvie.com. Follow@abbvieon Twitter or view careers on ourFacebook orLinkedInpage.

Forward-Looking StatementsSome statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

AASLD 2016 Conference Coverage – Merck

C-Crest: The trial was a phase 2 study of a 3-drug co-formulation of MK-3682 (polymerase inhibitor), grazoprevir (protease inhibitor) plus ruzasvir (NS5A inhibitor) with and without ribavirin to treat HCV genotypes 1, 2 and 3. The treatment period was 8, 12 or 16 weeks. In the people who were previously treated with pegylated interferon plus ribavirin the SVR12/cure rates were 95% to 100% in genotype 1a, 1b and 3. In people with genotype 2 the cure rate was 87% in the 8-week group and a 100% rate in the 12 week group and 96% to 98% in the 16 week groups. There was very little difference in cure rates between the groups who had cirrhosis, and who did/did not receive ribavirin.

C-Surge: An on-going phase 2 study to treat people with genotype 1 who had failed a previous course of a direct-acting antiviral therapy (Harvoni or Zepatier) using MK-3682, grazoprevir and ruzasvir with and without ribavirin. In the group that received ribavirin the treatment duration was 16 weeks; in the group that did not receive ribavirin the treatment duration was 24 weeks. The SVR 8 results were 98% in the 16 week group that received ribavirin and 100% in the 24 week group that did not receive ribavirin.

Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website

Four studies of AbbVie’s two drug combination—glecaprevir (protease inhibitor) and pibrentasvir (NS5A inhibitor) were presented.

Endurance 1:703 genotype 1 non-cirrhotic treatment naïve and treatment experience patients. The patients were treated for 8 or 12 weeks. No ribavirin was used in the study. The cure rates were 99% to 100% across all treatment groups. Endurance 2: 199 genotype 2 non-cirrhotic treatment-naïve and treatment-experience patients treated for 12 weeks achieved 99% to 100%.

Surveyor-II Part 3 Phase 2/3: In genotype 3 patients who were cirrhotic and treatment experienced but who had not been previously treated with a NS5A inhibitor were treated with glecaprevir plus pibrentasvir. Those treated for 12 weeks achieved 91% to 98% cure rates and those treated for 16 weeks achieved 96% cure rates. This treatment was particularly effective for people with end-stage kidney disease.

Surveyor-II Part 4: In genotype 2, 4, 5 or 6 patients without cirrhosis. There were a total of 203 patients—both treatment naïve and treatment experienced (no NS5A treatment experienced). The treatment period was 8 weeks. The cure rates were 98% for genotype 2; 93% for genotype 4; 100% for genotype 5 and 90% for genotype 6—although the number of patients in the genotype 5 and 6 groups were very small.

Expedition-IV: The goal of the study was to treat patients with renal impairment. There were 104 genotype 1 through 6 patients enrolled. The majority of the patients had severe renal impairment, and 82% were on dialysis (filtering of the blood because the kidneys are impaired). The patients were treatment naïve and treatment experienced (no NS5A experienced). The cure rate was 99% (103 of 104)—one patient discontinued treatment before the trial ended.

AbbVie has submitted their study results to the Food and Drug Administration forapproval inDecember.

Alan Franciscus is the Executive Director of the Hepatitis C Support Project and Editor-in-Chief of the HCV Advocate.

People who Inject Drugs (PWIDs) and who are infected with hepatitis C are not generally considered for hepatitis C treatment except in clinical trials. This is troubling because PWIDs are now the largest group of people who are at risk of acquiring hepatitis C. Additionally, a strategy to eliminate hepatitis C has to include a strategy to treat the most at-risk population. This year’s Conference included a presentation “Treatment of HCV in People Who Inject Drugs” by Jason Grebely. I am only going to cover the cure rates and re-infection rates from Dr. Grebely’s presentation.

Treatment: In various phase 3 clinical trials of people on HCV direct-acting antiviral medications the cure rates were 92% to 96% in people on opioid substitution therapy vs. 95% to 98% in people who were not on opioid substitution therapy (OST). In one of the largest clinical trials of people who inject drugs—C-EDGE Co-STAR (elbasvir/grazoprevir), genotypes 1, 4 and 6, treatment naïve patients, fibrosis stage F0 through F4, 12 week treatment duration the cure rate was genotype 1a: 96% (146 of 152 pts) ; genotype 1b: 97% (28 of 29 pts); genotype 4: 100% (11 of 11 pts); genotype 6: 60% (3 of 5 pts). The adherence in the group was 96%.

In other clinical trials of ‘real world’ study of people who inject drugs (heroin 66%; cocaine 62%; other stimulants 46%; OST 40%) and treated with different direct-acting antiviral medications the overall cure rate was 95%.

An overview of reinfection rates after being cured of hepatitis C among PWID were 2% to 3% in people who had a history of reinfection, 6% per year in people who injected drugs after achieving a cure and in one study presented at AASLD 4% per year in people on OST. There was no information given about prevention education—the most important component when treating people who are actively using drugs.

Alan Franciscus is the Executive Director of the Hepatitis Support Project and Editor-in-Chief of the HCV Advocate Website.

The incidence of liver cancer is rising. Several studies looked at how effective the medical profession is doing at screening for hepatocellular carcinoma (HCC).

Conclusion:These three large studies (two in the U.S. and one in the Netherlands) concluded that surveillance is poor.

Editorial Comments:If you have cirrhosis or hepatitis B (with/without cirrhosis), talk to your doctor about HCC screening recommendations. In the U.S., screening includes imaging (ultrasound, CT, or MRI) every 6 months.

Alcohol and hepatitis C treatment has always been a thorny issue. The current study examined the association between alcohol use and antiviral treatment. The study was conducted in the Veterans Affairs (VA) healthcare system during January 01, 2014 through June 30, 2015. The tool used to screen for alcohol consumption was the Alcohol Use Disorder Identification Consumption (AUDIT-C) questionnaire within the one-year before starting treatment. During the study period, 17,487 Veterans initiated DAA therapy. Of those 15,151 (87%) had completed the AUDIT-C questionnaire within one year. The antiviral therapies included sofosbuvir, sofosbuvir/ledipasvir (Harvoni) or Vikiera-Pak.

AUDIT-C scores categorized as follows: 0 (abstinence), 1-3 (low-level drinking) and 4-12 (unhealthy drinking) in men or 0, 1-2 and 3-12 in women.

The patient population was mostly male (96.7%), 28.9% were black, 30% had cirrhosis, mean age was 61 ±7 years and the distribution of HCV genotypes was 1 (79.8%), 2 (12.5%), 3 (7.0%) and 4 (0.8%).

Conclusion:The SVR/cure rate was: abstinent group: 91%; low-level group: 93%; unhealthy drinking 91%. Additionally, HCV genotype, cirrhosis, or HIV status was not associated with SVR. Alcohol use had no effect on cure rates in the people who used alcohol or in those who did not.

Editorial Comments: This study is a large population-based study that proves that drinking alcohol does not lower the chances of achieving an SVR/CURE. For this reason, people with hepatitis C should not be denied treatment just because they consume alcohol. It’s as simple as that, and we should take out the moral judgment that frequently taints the decision-making process of who receives treatment and who doesn’t. (For related content, see Lucinda K. Porter’s coverage of abstract #17691)